Merck recently won FDA approval for its sotatercept-csrk Winrevair for treating adults with pulmonary arterial hypertension. The drug was approved to increase exercise capacity and reduce the risk of clinical worsening events, according to the Rahway, N.J.-based company. It previously received FDA breakthrough designation and is the first FDA-approved action signaling inhibitor therapy for pulmonary…

The concept of a “batch size one” in pharmaceutical manufacturing is closer than ever. There are companies advancing cell therapies in which body cells are used to heal or support the individual patient. These cells are manipulated or edited to change certain biological characteristics before being transferred to the patient. Personalized medicine is truly about…

Sen-Jam Pharmaceutical this week announced it is partnering with specialty pharmaceutical manufacturer KVK-Tech for formulation and chemistry, manufacturing and controls for anti-inflammatory injectables. The partnership is the third development, manufacturing, distribution and license agreement the pair have signed. The new partnership will further advance Sen-Jam’s first injectable anti-inflammatory therapeutic, SJP-100. Sen-Jam is developing an immunomodulator…

Telix Pharmaceuticals announced that it agreed to acquire radioisotope production technology firm ARTMS Inc. ARTMS also brings with it an advanced cyclotron-based isotope production platform and manufacturing plant. It has a stockpile of ultra-pure rare metals required for consumable target production, too, according to a news release. The company specializes in the physics, chemistry and…

Japanese health authorities searched a Kobayashi Pharmaceutical factory in Japan following reports of five deaths related to dietary supplements, Reuters reports. The plant inspection in western Japan is the second in recent days as health authorities inspected the company’s Osaka facility. In addition to the five reported deaths, there have been more than 100 hospitalizations…